Strides Pharma Science Limited said that its stepdown fully-owned subsidiary — Strides Pharma Global Pte. Limited, Singapore, has secured approval from the US Food and Drug Administration (FDA) for Ibuprofen Oral Suspension USP, 50 mg/1.25 mL (40 mg/mL) (OTC).
The pain drug product from Strides Pharma is the generic of GlaxoSmithKline Consumer Healthcare Holdings (US)’s Infants’ Advil Concentrated Drops, 50 mg/1.25 mL (40 mg/mL) (OTC).
According to Strides Pharma Science, the FDA approval of its product further bolsters its Ibuprofen franchise for the American markets.
Strides Pharma Global was given a Competitive Generic Therapy (CGT) designation by the FDA for its ANDA. Its product is the “first approved applicant” for Ibuprofen Oral Suspension USP, 50 mg/1.25 mL (40 mg/mL) (OTC).
The company will have a 180 days of Competitive Generic Therapy (CGT) exclusivity for Ibuprofen Oral Suspension USP, 50 mg/1.25 mL (40 mg/mL) (OTC), under section 505(j)(5)(B)(v) of the FD&C Act.
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